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510(k) K791770

QUANTIMUNE GENTAMICIN RIA GENTAMICIN by Bio-Rad — Product Code DJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
September 7, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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Other clearances for product code DJB

  • K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM (September 29, 1983)
  • K831210 — GENTAMICIN TEST PACK-ACA (May 25, 1983)
  • K821669 — AMES TDA GENTAMICIN TEST (December 15, 1982)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K811844 — COAT-A-COUNT GENTAMICIN RIA KIT (July 10, 1981)
  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K791547 — FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (October 12, 1979)
  • K782049 — BIOASSAY SYSTEM, MS-2 SERUM (August 28, 1979)
  • K790584 — AMES TDA/GENTGMICIN (June 15, 1979)
  • K790829 — EMIT GENTAMICIN ASSAY (May 15, 1979)